Psychoeducational Programme for PD Patients With STN-DBS

Parkinson's Disease Clinical Trial

— PSYCHE  

Official title:

Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554370
• Other study ID #: 2006-A00230-51
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 17, 2015
• Start date: February 2008
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.

Description:

After inclusion, patients (and their caregivers) are randomized into two groups stratified on their preoperative social adjustment scale couple domain score : usual treatment and psychoeducational programme or usual treatment alone (Figure). The psychoeducational programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2) social life including work, social and familial relationship, 3) couple relationship. The programme consists of 7 sessions with 3 to 4 couples at the same session, except for the 'couple relationship' domain. Each domain is tackled in a two-way manner with information/education proved by the investigator and discussion of the patients' and caregivers' expectations during one session. The following session started with a 'Questions and Answers' on the previous domain and then information on another domain. Four sessions were carried out prior to surgery and 3 after.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Parkison's disease

• Patients candidate for STN DBS

• Caregiver agreeing to participate

• Signed informed consent

Exclusion Criteria:

• Contra-indication to STN-DBS

• No caregiver agreeing to participate

• Dementia

• Severe ongoing psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Psychoeducational programme
4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique GHPS	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social adjustment scale		Change from baseline at 1 year after surgery	No
Secondary	Parkinson's disease Questionnaire PDQ-39	Quality of life	Change from baseline at 1 and 2 years after surgery	No
Secondary	Anxiety scale (STAI)	STAI	Change from baseline at 1 and 2 years after surgery	No
Secondary	Mattis dementia rating scale	mattis dementia rating scale	Change from baseline at 1 and 2 years after surgery	No
Secondary	Parkinsonian disability (Unified Parkinson's Disease Rating Scale)	Unified Parkinson's Disease Rating Scale	Change from baseline at 1 and 2 years after surgery	No
Secondary	Dopaminergic treatment dosage (mg/day)	Daily dosage of dopaminergic agents	Change from baseline at 1 and 2 years after surgery	No
Secondary	Social adjustment scale		Change from baseline at 2 years after surgery	No